作者
Ian T Meredith AM, Darren L Walters, Nicolas Dumonteil, Stephen G Worthley, Didier Tchétché, Ganesh Manoharan, Daniel J Blackman, Gilles Rioufol, David Hildick-Smith, Robert J Whitbourn, Thierry Lefèvre, Rüdiger Lange, Ralf Müller, Simon Redwood, Dominic J Allocco, Keith D Dawkins
发表日期
2014/9/30
期刊
Journal of the American College of Cardiology
卷号
64
期号
13
页码范围
1339-1348
出版商
American College of Cardiology Foundation
简介
Background
Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).
Objectives
The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.
Methods
Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was …
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IT Meredith AM, DL Walters, N Dumonteil, SG Worthley… - Journal of the American College of Cardiology, 2014